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Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Aripiprazole
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Acute Schizophrenia, Psychotropic Drugs, Aripiprazole, Antipsychotic Agents, Mental Disorders, Dopamine Agents, Central Nervous System Agents

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have provided informed consent prior to any study specific procedures
  • Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
  • Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
  • Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1
  • Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
  • CGI-S score ≥ 4

Exclusion Criteria:

  • Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
  • Bipolar I and II disorder
  • Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
  • DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
  • Women who are pregnant or breast feeding

Sites / Locations

  • Woodland International Research Group, Inc.
  • Woodland Research Northwest, LLC
  • Synergy Clinical Research of Escondido
  • Excell Research, Inc
  • Clinical Innovations, Inc.
  • Sharp Mesa Vista Hospital
  • Collaborative Neuroscience Network, Inc.
  • Colorado Clinical Trials, Inc.
  • Comprehensive Clinical Development, Inc.
  • Florida Clinical Research Center, LLC
  • Hawaii Clinical Research Center
  • Uptown Research Institute, LLC
  • Alexian Brothers Center for Psychiatric Research
  • Precise Research Centers
  • Millennium Psychiatric Associates, LLC
  • CRI Worldwide, LLC
  • Windsor-Laurelwood Center for Behavioral Medicine
  • Vanderbilt Psychiatric Hospital
  • Claghorn-Lesem Research Clinic, Ltd.
  • Pacific Institute of Medical Sciences
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie
  • Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie
  • Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie
  • Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III
  • Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie
  • Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie
  • Spitalul Judetean de Urgenta Piatra Neamt
  • Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie
  • Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu
  • Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie
  • Spitalul Clinic Judetean Mures, Clinica Psihiatrie I
  • Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"
  • Healthcare Institution "Moscow Regional Mental Hospital #5"
  • State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>
  • State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"
  • State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav"
  • St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko"
  • Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"
  • State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"
  • St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"
  • Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Ministry of Health and Social Development of the Russian Federation, Department of biological therapy of mental patients
  • State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"
  • Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Minitstry of Health and Social Development of the Russian Federation
  • St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"
  • St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7
  • Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"
  • Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14
  • I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology
  • Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology
  • Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology
  • Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14
  • State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology
  • Kherson Regional Psychiatric Hospital, Department #3
  • Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions
  • Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female)
  • O.F. Maltsev Poltava Regional Clinical Psychiatric Hopspital, Department #3B, State Institution of Higher Education of Ukraine: Ukranian Medical Stomatological Academy, Chair of Psychiatry, Narcology and Medical Psychology
  • Crimean Republican Institution: Clinical Psychiatric Hospital #1, Female Psychiatric Department #2, Male Psychiatric Department #1, S.I. Georgiyevskyy Crimean State Medical University, Chair of Psychiatry, Psychotherapy and Narcology
  • O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Cariprazine 3mg

Cariprazine 6mg

Aripiprazole 10mg

Placebo

Arm Description

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Outcomes

Primary Outcome Measures

Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.

Secondary Outcome Measures

Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement.

Full Information

First Posted
April 9, 2010
Last Updated
October 26, 2018
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01104766
Brief Title
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Official Title
A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 23, 2010 (Actual)
Primary Completion Date
December 20, 2011 (Actual)
Study Completion Date
December 20, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Acute Schizophrenia, Psychotropic Drugs, Aripiprazole, Antipsychotic Agents, Mental Disorders, Dopamine Agents, Central Nervous System Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
617 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine 3mg
Arm Type
Experimental
Arm Description
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Arm Title
Cariprazine 6mg
Arm Type
Experimental
Arm Description
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Arm Title
Aripiprazole 10mg
Arm Type
Active Comparator
Arm Description
Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Other Intervention Name(s)
RGH-188
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Primary Outcome Measure Information:
Title
Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
Description
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
Description
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement.
Time Frame
Baseline to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have provided informed consent prior to any study specific procedures Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG) Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1 Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120 CGI-S score ≥ 4 Exclusion Criteria: Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders Bipolar I and II disorder Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study Women who are pregnant or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffaele Migliore, MA
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Woodland International Research Group, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest, LLC
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Synergy Clinical Research of Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Excell Research, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Colorado Clinical Trials, Inc.
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80130
Country
United States
Facility Name
Comprehensive Clinical Development, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Hawaii Clinical Research Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Uptown Research Institute, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Millennium Psychiatric Associates, LLC
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CRI Worldwide, LLC
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Windsor-Laurelwood Center for Behavioral Medicine
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Vanderbilt Psychiatric Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Claghorn-Lesem Research Clinic, Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Pacific Institute of Medical Sciences
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie
City
Bucuresti
ZIP/Postal Code
41914
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie
City
Bucuresti
ZIP/Postal Code
41914
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie
City
Craiova
ZIP/Postal Code
200620
Country
Romania
Facility Name
Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie
City
Craiova
ZIP/Postal Code
200745
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Piatra Neamt
City
Piatra Neamt
ZIP/Postal Code
610136
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie
City
Pitesti
ZIP/Postal Code
110069
Country
Romania
Facility Name
Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu
City
Sibiu
ZIP/Postal Code
550082
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie
City
Targoviste
ZIP/Postal Code
130086
Country
Romania
Facility Name
Spitalul Clinic Judetean Mures, Clinica Psihiatrie I
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Healthcare Institution "Moscow Regional Mental Hospital #5"
City
Orekhovo-Zuyevo
State/Province
Moscow Region
ZIP/Postal Code
142601
Country
Russian Federation
Facility Name
State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>
City
Arkhangelsk
ZIP/Postal Code
163530
Country
Russian Federation
Facility Name
State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav"
City
Chita
ZIP/Postal Code
672090
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko"
City
Gatchina
ZIP/Postal Code
188357
Country
Russian Federation
Facility Name
Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Ministry of Health and Social Development of the Russian Federation, Department of biological therapy of mental patients
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Minitstry of Health and Social Development of the Russian Federation
City
St. Petersburg
ZIP/Postal Code
1922019
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"
City
St. Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14
City
Village Glevakha
State/Province
Kyiv
ZIP/Postal Code
08613
Country
Ukraine
Facility Name
I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Hospital, Department #3
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female)
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
O.F. Maltsev Poltava Regional Clinical Psychiatric Hopspital, Department #3B, State Institution of Higher Education of Ukraine: Ukranian Medical Stomatological Academy, Chair of Psychiatry, Narcology and Medical Psychology
City
Poltava
ZIP/Postal Code
36006
Country
Ukraine
Facility Name
Crimean Republican Institution: Clinical Psychiatric Hospital #1, Female Psychiatric Department #2, Male Psychiatric Department #1, S.I. Georgiyevskyy Crimean State Medical University, Chair of Psychiatry, Psychotherapy and Narcology
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology
City
Vinnytsya
ZIP/Postal Code
49005
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
26845266
Citation
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Results Reference
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PubMed Identifier
28692485
Citation
Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187.
Results Reference
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PubMed Identifier
28836957
Citation
Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Nemeth G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z.
Results Reference
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PubMed Identifier
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Citation
Durgam S, Cutler AJ, Lu K, Migliore R, Ruth A, Laszlovszky I, Nemeth G, Meltzer HY. Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placebo- and active-controlled trial. J Clin Psychiatry. 2015 Dec;76(12):e1574-82. doi: 10.4088/JCP.15m09997.
Results Reference
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PubMed Identifier
34091867
Citation
Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.
Results Reference
derived
PubMed Identifier
33854317
Citation
Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021. Erratum In: Neuropsychiatr Dis Treat. 2021 May 17;17:1481.
Results Reference
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PubMed Identifier
30470662
Citation
Marder S, Fleischhacker WW, Earley W, Lu K, Zhong Y, Nemeth G, Laszlovszky I, Szalai E, Durgam S. Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: Pooled analyses from 3 phase II/III studies. Eur Neuropsychopharmacol. 2019 Jan;29(1):127-136. doi: 10.1016/j.euroneuro.2018.10.008. Epub 2018 Nov 20.
Results Reference
derived
PubMed Identifier
28478771
Citation
Cutler AJ, Durgam S, Wang Y, Migliore R, Lu K, Laszlovszky I, Nemeth G. Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study. CNS Spectr. 2018 Feb;23(1):39-50. doi: 10.1017/S1092852917000220. Epub 2017 May 8.
Results Reference
derived

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Safety and Efficacy of Cariprazine in Patients With Schizophrenia

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